Mechanisms, Safety and Efficacy of Optimising Pacemaker Heart Rate for Contractility: Effects on Walk Time, Cardiac Remodelling and Quality of Life

What this Trial Is About

Researchers are studying patients with chronic heart failure (CHF) who have pacemakers to find out if adjusting the heart rate settings on their devices can improve their exercise ability and quality of life. This trial compares three programming approaches: optimal rate-response based on heart contractility, standard rate-response, and no rate-response programming. The study aims to see if these adjustments affect treadmill walk time, heart function, and battery life over six months. The trial involves programming pacemakers according to the patient's force-frequency relationship to set an optimal heart rate range. Participants are randomly assigned to one of three groups: optimized rate-response settings, standard settings, or no rate-response settings. After initial assessments, including echocardiograms and treadmill tests, patients receive their assigned programming and are followed for six months. During this time, their heart function and quality of life are monitored, and some may join additional substudies involving cardiac MRI, blood tests, and autonomic function tests. Participants attend a research facility for initial evaluations, including heart ultrasound, treadmill exercise tests, and questionnaires about their quality of life. After randomization and device programming, they receive a follow-up phone call at one month and return for a repeat of the tests at six months. The study measures changes in treadmill walk time as the primary outcome, along with cardiac function, quality of life, and safety. Data is securely stored and analyzed to understand the effects of heart rate programming on heart failure patients with pacemakers.

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